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Strumph v. Schering Corp.

May 21, 1992


On appeal from Superior Court of New Jersey, Law Division, Atlantic County.

Pressler, Skillman and D'Annunzio. The opinion of the court was delivered by D'Annunzio, J.A.D. Skillman, J.A.D., Dissenting.



This is a product liability action against Schering Corporation, the manufacturer of a drug marketed under the name Trilafon. Plaintiff, Nancy Strumph, alleges that she developed neuroleptic malignant syndrome (NMS) as a result of her ingestion of Trilafon, a neuroleptic drug, which had been prescribed by her treating physician. Schering's liability is posited on the contention that it did not adequately warn of the risk of NMS. Plaintiff now appeals from a summary judgment entered on the ground that plaintiff could not establish that defendant's allegedly inadequate warning was a proximate cause of her injury.

Plaintiff, diagnosed as a paranoid schizophrenic and depressive, has a long history of psychiatric illnesses that required medical treatment. The drug Stelazine, also a neuroleptic medication, had been effective in treating plaintiff's condition, and she was maintained on a regimen of Stelazine and Thorazine from September 1982 through June 1986. However, in June 1986, plaintiff attempted suicide by overdosing on Stelazine and slashing her wrists.

She was admitted to the Atlantic City Medical Center, through the emergency room, where she came under the care of Dr. Norman Chazin, a board certified psychiatrist. Dr. Chazin selected Trilafon to treat appellant's paranoid schizophrenia.

Dr. Chazin explained during his deposition that he selected Trilafon because:

In reviewing the patient's history of medications and the difficulty that she had with several of the ones that I had mentioned previously, Trilafon had not been tried.

Trilafon is an effective neuroleptic medication that I have had ample experience with, and this appeared to be a reasonable treatment choice for the patient.

Chazin also prescribed Cogentin and Lithium to assist in treating appellant's conditions. Plaintiff tolerated the prescribed medications well and her condition improved. She was discharged from the Atlantic City Medical Center on June 10, 1986 on a regimen of Trilafon, Cogentin and Lithium, with instructions to see her private treating psychiatrist. In July 1986, plaintiff was hospitalized with NMS symptoms. The record suggests that she suffered from substantial disabilities allegedly caused by ingestion of Trilafon. Whether Trilafon was a cause in fact of plaintiff's injury is a disputed fact not material to the issue on appeal.

In 1986, defendant, Schering Corporation, warned of the risk of NMS. The Physician's Desk Reference (PDR) entry for Trilafon stated in an unhighlighted block of text under the heading "CNS Effects":

Neuroleptic malignant syndrome has been reported in patients treated with neuroleptic drugs. It is a relatively uncommon, potentially lethal syndrome, characterized by severe extrapyramidal dysfunction, with rigidity and eventual stupor or coma; hyperthermia and autonomic disturbances, including cardiovascular effects. There is no specific treatment, the neuroleptic drug should be stopped immediately.

Plaintiff bases her liability case on the contention that defendant provided an inadequate warning of NMS as a risk of Trilafon therapy. Specifically, plaintiff contends that defendant failed to give proper prominence to the risk and consequences of NMS until the late 1980s at the earliest and that its 1986 warnings failed to communicate that risk with sufficient urgency. Plaintiff refers to the 1990 PDR reference for Trilafon as an example of a more adequate warning. In 1990, NMS is mentioned earlier in the text under the heading WARNINGS rather than later in the text under ADVERSE REACTIONS.

Moreover, in 1990 the subject is introduced with its own heading, NEUROLEPTIC MALIGNANT SYNDROME (NMS), rather than being "buried"*fn1 as a sub-topic under "Other CNS effects" under the general heading "Adverse Reactions."*fn2

Dr. John R. Rushton, who had been treating plaintiff for many years prior to her June 3, 1986 hospital admission, testified on deposition that in 1986 he would have "veered away from" Trilafon because of its risk of causing NMS. In a letter to plaintiff's counsel dated December 7, 1989, Rushton stated, "I avoid the use of Trilafon, turning to medicine less predisposed to bring on a neuroleptic malignant syndrome." Rushton also stated that the warning given by Schering Corporation in 1986 was inadequate. Plaintiff's other expert, Dr. Frederick J. Goldstein, concurred in this assessment.

Dr. Chazin was deposed on October 30, 1990. He testified that he was aware of the risk of NMS associated with Trilafon when he prescribed the medication to appellant and that if a different warning of the risk of NMS had been placed in the drug's package insert or PDR reference, he still would have prescribed Trilafon to the appellant:

Q. When you prescribed the Trilafon for her, were you aware of the fact that there were potential risks and side effects to the use of that medication?

A. I was aware of that, yes.

Q. Knowing all of those potential risks and side effects, you still decided to prescribe the drug Trilafon for Nancy Strumph?

A. That's correct.

Q. Why?

A. The neuroleptic benefit far outweighed the possibility of the development of the side effects that you have mentioned.

Q. Doctor, I assume -- but please correct me if I'm wrong -- that you probably know a little bit more -- maybe its a lot more, but that you know more today,

1990, than you did in 1986, about Trilafon and some of its potential risks and side effects.

A. Yes, I think that that's true.

Q. Doctor, knowing everything that you know today about Trilafon and its potential side effects, and with particular reference to NMS, had you known that same knowledge, same information, in June, 1986, when you prescribed Trilafon for Nancy Strumph, would you still have prescribed the medication for her?

A. Yes.

Q. Doctor, before prescribing the Trilafon to Nancy Strumph, did you read the package insert or PDR insert on the medication?

A. No, I did not.

Q. What were the sources of your knowledge concerning the potential risks and side effects of Trilafon?

A. The source is both from my formal education in psychiatry, as well as my daily clinical experience.

Q. Doctor, had you read a package insert or a PDR insert on Trilafon back in 1986 that had the risk of NMS highlighted in large block print as it is in the [1990] PDR insert, would you still have prescribed the medication for Nancy Strumph?

A. Yes, I would.

Q. Doctor, if it had been highlighted like that but in bold red print to stick out even more, would you have prescribed the medication?

A. Yes, I would.

Q. If you saw Nancy Strumph today, October 30, 1990, under the same or similar circumstances that you saw her in June, 1986 and in the same or similar condition that she was in in June, 1986, if you saw her today, would you have -- would you prescribe Trilafon today to treat her condition?

A. Yes, I would.

Q. And that's knowing everything that you know today, in 1990, about Trilafon, its side effects and its risks, including, but not limited to, NMS?

A. That's right.

Following her discharge from the hospital by Dr. Chazin, the plaintiff saw Dr. Leo Brown, a private practicing psychiatrist at the Atlantic City Mental Health Center on June 13, 1986. Dr. Brown obtained a medical history, performed a psychiatric examination and diagnosed the plaintiff as suffering from paranoid schizophrenia and depression. He continued the plaintiff on Trilafon and Lithium.

Dr. Brown was deposed on October 23, 1990. Like Dr. Chazin, he also testified that he was fully aware of the risk of NMS associated with Trilafon and that highlighting the risk of NMS in the drug's package insert or PDR reference would not have affected his judgment or decision to continue to treat plaintiff with Trilafon:

Q. Doctor, at the time you prescribed and continued the Trilafon for Nancy Strumph, were you aware that there was a risk of NMS, neuroleptic malignant ...

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